MAUDE Adverse Event Report: MEDTRONIC / COVIDIEN SHILEY FLEXIBLE TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 8CN85H

Device Problem Leak/Splash (1354)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/17/2022

Event Type  Injury  

Event Description

Patient initially admitted to (b)(6) from home on (b)(6) 2022 for sob (shortness of breath) for two days and testing positive for covid.She was intubated in the emergency room due to severe hypoxemia.Patient failed weaning and was trached on (b)(6) 2022 with a (b)(4) and remained on mechanical ventilator.On (b)(6) 2022, patient was noted with a leak and desaturation.Patient was placed on 100% fio2 and pulmonologist (b)(6), do was contacted.Md came to assess patient and recommended the surgeon to change the trach.On (b)(6) 2022 at 0020, patient desaturated and became tachypneic, but was able to maintain adequate tidal volumes.Emergency trach change was performed by intensivist (b)(6) was fda safety report id # (b)(4).

• Brand Name: SHILEY FLEXIBLE TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MEDTRONIC / COVIDIEN
• MDR Report Key: 15265408
• MDR Text Key: 298391013
• Report Number: MW5111605
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8CN85H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 29 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian